Dosing & Uses
Dosage Forms & Strengths
injection, suspension
- 1mL (single-dose vial)
Immunization Against Ebola Zaire Virus
Indicated for prevention of disease caused by Zaire ebolavirus
1 mL IM once
ACIP recommendations
- Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommends preexposure vaccination for the following people who:
- Are responding to an outbreak of Ebola virus disease; or
- Work as healthcare personnel at federally-designated Ebola Treatment Centers (ETCs) in the U.S.; or
- Work as laboratorians or other staff at biosafety-level 4 facilities in the U.S.
Dosing Considerations
Limitations of use
- Duration of protection conferred by vaccine is unknown
- Does not protect against other species of Ebolavirus or Marburgvirus
- Effectiveness of vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown
Dosage Forms & Strengths
injection, suspension
- 1mL (single-dose vial)
Immunization Against Ebola Zaire Virus
Indicated for prevention of disease caused by Zaire ebolavirus in individuals aged ≥1 year
1 mL IM once
ACIP recommendations
- Centers for Disease Control and Prevention's (CDC's) Advisory Committee on Immunization Practices (ACIP) recommends preexposure vaccination for the following people who:
- Are responding to an outbreak of Ebola virus disease; or
- Work as healthcare personnel at federally-designated Ebola Treatment Centers (ETCs) in the U.S.; or
- Work as laboratorians or other staff at biosafety-level 4 facilities in the U.S.
Dosing Considerations
Limitations of use
- Duration of protection conferred by vaccine is unknown
- Does not protect against other species of Ebolavirus or Marburgvirus
- Effectiveness of vaccine when administered concurrently with antiviral medication, immune globulin (IG), and/or blood or plasma transfusions is unknown
Interactions
Interaction Checker
No Results
Contraindicated
Serious - Use Alternative
Significant - Monitor Closely
Minor
Contraindicated (0)
Serious - Use Alternative (16)
- abrocitinib
abrocitinib decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administration of live vaccines is not recommended during abrocitinib treatment and immediately before or after treatment.
- anifrolumab
anifrolumab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Before initiation, update immunization according to current guidelines.
- atoltivimab/maftivimab/odesivimab
atoltivimab/maftivimab/odesivimab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Ebola monoclonal antibodies may interfere with immune response of live vaccines. Refer to vaccine guidelines for vaccination timing during and following treatment. .
- axicabtagene ciloleucel
axicabtagene ciloleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- ciltacabtagene autoleucel
ciltacabtagene autoleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- cyclosporine
cyclosporine decreases effects of Ebola Zaire vaccine by pharmacodynamic antagonism. Contraindicated. Avoid live vaccines in immunocompromised patients due to the risk of developing a clinical infection from the live vaccine. Inadequate immune response to the vaccine may also occur in the presence of immunosuppressants. Avoid live vaccines for at least 3 months after cessation of immunosuppressant therapy unless the benefit of vaccine administration outweighs the potential risk.
- elivaldogene autotemcel
elivaldogene autotemcel, Ebola Zaire vaccine. Either decreases effects of the other by Other (see comment). Avoid or Use Alternate Drug. Comment: The safety and effectiveness of vaccination during or following elivaldogene autotemcel treatment have not been studied. Vaccination is not recommended during the 6 weeks preceding myeloablative conditioning, and until hematological recovery following elivaldogene autotemcel treatment. Where feasible, administer childhood vaccinations before myeloablative conditioning. .
- idecabtagene vicleucel
idecabtagene vicleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- ofatumumab SC
ofatumumab SC decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Administer all immunizations according to immunization guidelines at least 4 weeks prior to initiation of ofatumumab SC for live or live-attenuated vaccines, and whenever possible.
- ozanimod
ozanimod decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live-attenuated vaccines with ozanimod during treatment and for up to 3 months after discontinuing ozanimod. .
- ponesimod
ponesimod decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid use of live attenuated vaccines at least 1 month before initiating, during, and for 1-2 weeks after treatment. Coadministration with live attenuated vaccines may increase infection risk.
- ritlecitinib
ritlecitinib, Ebola Zaire vaccine. immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Avoid live attenuated vaccines during or shortly before initiating ritlecitinib. No data are available on vaccination response in ritlecitinib treated patients. Before initiating, review patient immunization status (including herpes zoster) and immunize accordingly in agreement with current immunization guidelines.
- satralizumab
satralizumab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. ive vaccines are not recommended during treatment. Administer all immunizations according to immunization guidelines. At least 4 weeks before initiating for live or live-attenuated vaccines.
- teplizumab
teplizumab decreases effects of Ebola Zaire vaccine by Other (see comment). Avoid or Use Alternate Drug. Comment: Administer all age-appropriate vaccinations before starting teplizumab. Live-attenuated vaccines are not recommended within 8 weeks before teplizumab treatment, during treatment, or up to 52 weeks after treatment.
- tisagenlecleucel
tisagenlecleucel decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Vaccination with live virus vaccines is not recommended for at least 6 weeks before starting lymphodepleting chemotherapy, during CAR-T cell treatment, and until immune recovery following treatment. .
- voclosporin
voclosporin decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Avoid or Use Alternate Drug. Immunosuppressants also increase risk of infection with concomitant live vaccines. Avoid live vaccines for at least 3 months after immunosuppressants.
Monitor Closely (3)
- betibeglogene autotemcel
betibeglogene autotemcel, Ebola Zaire vaccine. Other (see comment). Use Caution/Monitor. Comment: Follow institutional guidelines for vaccine administration. Safety of live vaccines during or following treatment not studied. .
- leniolisib
leniolisib decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Use Caution/Monitor. Live, attenuated vaccinations may be less effective if administered during leniolisib treatment.
- ublituximab
ublituximab decreases effects of Ebola Zaire vaccine by immunosuppressive effects; risk of infection. Modify Therapy/Monitor Closely. Administer all immunizations according to immunization guidelines at least 4 weeks before initiating ublituximab for live or live-attenuated vaccines and, whenever possible, at least 2 weeks before initiating for non-live vaccines. Vaccination with live virus vaccines is not recommended during treatment and until B-cell repletion. Do not administer live or live-attenuated vaccines to infants of mothers exposed to ublituximab during pregnancy, before confirming recovery of B-cell counts as measured by CD19+ B cells.
Minor (0)
Adverse Effects
>10%
Aged ≥18 years
- Injection site pain (34-69.5%)
- Headache (36.9%)
- Fever (34.3%)
- Muscle pain (32.5%)
- Fatigue (18.5%)
- Joint pain (17.9%)
- Injection site swelling (16.5%)
- Injection site redness (11.9%)
Aged 12-17 years
- Headache (59.1%)
- Injection-site pain (52.2%)
- Fever (48.3%)
- Myalgia (29.6%)
- Somnolence (28.1%)
- Decreased appetite (20.7%)
- Chills (19.2%)
- Dizziness (16.7%)
- Abdominal pain (15.8%)
- Arthralgia (15.8%)
Aged 3-11 years
- Fever (64.8%)
- Headache (49.7%)
- Injection-site pain (39.4%)
- Decreased appetite (23.9%)
- Somnolence (21.6%)
- Abdominal pain (21%)
- Chills (14.2%)
- Myalgia (11.6%)
- Vomiting (11%)
Aged 1-2 years
- Fever (83.2%)
- Crying (30.5%)
- Decreased appetite (27.4%)
- Injection-site pain (26.3%)
- Somnolence (20%)
- Diarrhea (18.9%)
- Vomiting (16.8%)
- Irritability (10.5%)
1-10%
Aged ≥18 years
- Nausea (8%)
- Joint pain/tenderness (7%)
- Arthritis (0.8-4.7%)
- Rash (3.6-3.8%)
- Abnormal sweating (3.2%)
- Local reactions (eg, redness, swelling) (1.8%)
- Vesicular lesions (1.5%)
Aged 12-17 years
- Nausea (8.4%)
- Abnormal sweating (4.9%)
- Diarrhea (3.9%)
- Vomiting (3.9%)
- Injection-site swelling (2.5%)
- Injection-site pruritus (2.5%)
- Mouth ulceration (1.5%)
Aged 3-11 years
- Dizziness (8.4%)
- Nausea (8.4%)
- Injection-site pruritus (6.5%)
- Crying (3.2%)
- Arthralgia (3.2%)
- Diarrhea (2.9%)
- Injection-site swelling (2.6%)
- Mouth ulceration (1.9%)
- Abnormal sweating (1.3%)
- Irritability (1%)
Aged 1-2 years
- Screaming (9.5%)
- Mouth ulceration (6.3%)
- Chills (5.3%)
- Injection-site swelling (5.3%)
- Headache (4.2%)
- Abdominal pain (2.1%)
- Abnormal sweating (2.1%)
- Injection-site erythema (1.1%)
<1%
Aged ≥18 years
- Arthropathy (joint redness/warmth) (0.6%)
- Joint swelling (0.4%)
- Joint stiffness (0.4%)
Aged 12-17 years
- Injection-site erythema (0.5%)
Aged 3-11 years
- Screaming (0.6%)
- Injection-site erythema (0.3%)
Warnings
Contraindications
Hypersensitivity to any component of the vaccine, including rice protein
Cautions
There were 2 reports of anaphylaxis; monitor for signs and symptoms of hypersensitivity reactions following vaccination; appropriate medical treatment and supervision must be available in case of an anaphylactic event following administration
Vaccination may not protect all individuals; vaccinated individuals should continue to adhere to infection control practices to prevent Zaire ebolavirus infection and transmission
Safety and effectiveness have not been assessed in immunocompromised individuals; weigh the risk of vaccination in immunocompromised individuals against the risk of disease due to Zaire ebolavirus
Vaccine virus RNA has been detected by RT-PCR in blood, saliva, urine, and fluid from skin vesicles of vaccinated adults; transmission of vaccine virus is a theoretical possibility
Drug interaction overview
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Interference with laboratory tests
- Following vaccination, individuals may test positive for anti-Ebola glycoprotein (GP) antibody and/or Ebola GP nucleic acid or antigens
- GP-based testing may have limited diagnostic value during period of vaccine viremia, in the presence of vaccine-derived Ebola GP, and following antibody response to the vaccine
Pregnancy & Lactation
Pregnancy
There are no adequate and well-controlled studies in pregnant women, and human data available from clinical trials are insufficient to establish the presence or absence of vaccine-associated risk during pregnancy
Consider the woman’s risk of exposure to Zaire ebolavirus before vaccination
Clinical considerations
- Fetal and neonatal outcomes are universally poor among pregnant women infected with Zaire ebolavirus
- Majority of such pregnancies end in miscarriage or stillbirth
- In pregnancies where live birth does occur, neonates generally do not survive
- Potential for transmission of the vaccine virus from mother to the fetus/neonate is unknown
Lactation
Human data are not available to assess the effects on milk production, its presence in breast milk, or its effects on the breastfed child
Consider developmental and health benefits of breastfeeding along with the mother’s clinical need and any potential adverse effects on the breastfed child or from the underlying maternal condition
For preventive vaccines, the underlying condition is susceptibility to disease prevented by the vaccine
Pregnancy Categories
A: Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.
B: May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk. C: Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done. D: Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk. X: Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist. NA: Information not available.Pharmacology
Mechanism of Action
Recombinant vesicular stomatitis virus-Zaire ebolavirus (rVSV-ZEBOV; V920) is a replication-competent vaccine
Genetically engineered to express a glycoprotein from the Zaire ebolavirus to provoke a neutralizing immune response to the Ebola virus
Administration
IM Preparation
Thaw vial at room temperature until no visible ice is present; do not thaw vial in a refrigerator
Gently invert vial several times
Visually inspect for particulate matter and discoloration before use, vaccine is a colorless to slightly brownish-yellow liquid with no particulates visible
Use the vaccine immediately after thawing
Withdraw 1-mL dose from vial using a sterile needle and sterile syringe
IM Administration
Administer a 1-mL dose IM, preferably in the deltoid area of the nondominant arm
Discard unused portion
Storage
Unopened vials: Freeze at -80 to -60ºC (-112 to -76ºF) in the original carton to protect from light; do not thaw the vial in a refrigerator
Thawed vials: If not used immediately, refrigerate at 2-8ºC (35.6-46.4ºF) for a total time of no more than 2 weeks and at room temperature (up to 25ºC; 77ºF) for a total time of no more than 4 hr
Do not refreeze
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Formulary
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